DEVICE: Five Panel PreScreen Plus Mini Cup (CLIA Waived) (00851000007168)
Device Identifier (DI) Information
Five Panel PreScreen Plus Mini Cup (CLIA Waived)
PSC-DOA-254M
In Commercial Distribution
MERGERS MARKETING, INC.
PSC-DOA-254M
In Commercial Distribution
MERGERS MARKETING, INC.
Five Panel PreScreen Plus Mini Cup (CLIA Waived) Drug Combo: COC|AMP|MAMP|THC|OPI
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
46994 | Multiple drugs of abuse IVD, kit, rapid ICT, clinical |
A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DJG | Enzyme Immunoassay, Opiates |
LDJ | Enzyme Immunoassay, Cannabinoids |
LAF | Gas Chromatography, Methamphetamine |
DKZ | Enzyme Immunoassay, Amphetamine |
DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
d9ac862f-eba7-4ba7-b098-20307db7ece6
June 10, 2022
4
December 07, 2016
June 10, 2022
4
December 07, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
20851000007162 | 4 | 10851000007165 | In Commercial Distribution | Case | |
10851000007165 | 25 | 00851000007168 | In Commercial Distribution | Inner Pack |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined